Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.” The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations. However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.
Reason to Introduce the TEMA
The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic. In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review. According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.” Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).
However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions. For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020. The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020. Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.
The Commission’s new draft Regulation therefore proposes to introduce TEMAs. The Commission envisages that TEMAs will provide a faster way of authorizing useful medicines in a public health emergency. The Commission’s TEMA process will continue to run alongside Member State powers “to temporarily authorise the use and distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm” (Article 3(2) of the draft Directive). However, the TEMA will be granted on a coordinated EU-level, rather than a Member State-by-Member State basis.
Criteria and Conditions
The Commission will only grant TEMAs when there is a recognized and ongoing “public health emergency” at Union level in accordance with Article 23 of Regulation (EU) 2022/2371. The Commission can grant a TEMA before the availability of complete quality, preclinical, clinical and environmental data and provided the medicinal product is “intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency.” (Article 30)
Additionally, Article 31 requires that for the Commission to grant a TEMA:
- there must be no other satisfactory method of treatment, prevention or diagnosis authorized/available, or, if one exists, the TEMA “will contribute to address the public health emergency;” and
- based on scientific evidence available, the EMA must have issued an opinion concluding the product could be effective in treating, preventing or diagnosing the disease/condition directly related to the public health emergency and the known potential benefits outweigh the known potential risks.
Article 33 requires that each TEMA will be subject to “specific conditions.” These could include conditions on manufacturing, use, supply and safety monitoring and compliance with related good manufacturing, and pharmacovigilance practices. They may also specify the batches of product and requirements around clinical trials (e.g., ensuring products are safe and effective or minimise impact on the environment). The EMA will review these conditions annually.
Procedure to Obtain a TEMA
Articles 32 and 33 of the draft Regulation set out the procedure for obtaining a TEMA. In short, it requires the EMA to ensure the CHMP gives its opinion “without undue delay” and take into account the recommendation of the Emergency Task Force (established under Regulation (EU) 2022/123) and any relevant data. The EMA should transmit its opinion to the Commission but should also review new evidence and update its opinion as necessary. The Commission will then take a decision by implementing act.
If the Commission grants a TEMA, Member States must withdraw any authorization for “use of medicinal products containing the same active substance for any indications that are subject to the temporary marketing authorisation” granted nationally in accordance with Article 3(2) of the revised Directive.
How Long Does a TEMA Last?
A TEMA will immediately cease to be valid when the Commission terminates recognition of the applicable public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371 (Article 34). Additionally, the Commission may suspend, revoke or vary the TEMA in order to protect public health or when the marketing authorization holder has not complied with the conditions and obligations set out in the TEMA.
Where a TEMA is suspended, revoked (for any reasons other than safety) or ceases to be valid then a Member State may in “exceptional circumstances” allow patients already treated with it to continue to be treated with it for a transitional period (Article 37). Thus, Member States could allow patients already using the medicine to continue to use it following the end of the public health emergency. However, new patients could not receive it.
TEMA marketing authorization holders can also apply for a full or conditional marketing authorization following the end of the public health emergency, provided they have sufficient data to support the application. For the purpose of regulatory data protection, the TEMA and any subsequent marketing authorization will be considered as part of the same global marketing authorization.
During the pandemic, the EU trailed behind other key jurisdictions, like the UK and US, in approving COVID-19 vaccines. Both the UK and US used emergency authorization procedures. The Commission is therefore proposing to introduce the TEMA as an “agile, fast and streamlined” process to authorize medicines in any future public health emergencies.
In order to grant a TEMA, the Commission must first recognize a public health emergency. Public health emergency is not defined in the draft Regulation but is defined in Council Regulation (EU) 2372 as “a public health emergency at Union level recognized by the Commission in accordance with Article 23 of Regulation (EU) 2022/2371.” Thus, satisfaction of this requirement may well be politically driven and is likely to be the rate-limiting step, particularly given that the Commission must liaise with the WHO before recognizing such an emergency. Although we hope TEMAs will not be needed, in the event of a future pandemic or public health emergency, we query how useful this new procedure will be in practice over alternative existing mechanisms.
This blog is based on the wording of the EU’s proposal published on 26 April 2023. This wording could significantly change during the legislative process. Our Dublin, Brussels, Frankfurt and London teams will continue to monitor this legislation. We will be hosting a webinar to discuss the impact on 9 May. To sign up for the webinar please click here.